Evaluation of the Effect of Suzetrigine (SUZ) on the Pharmacokinetics of Oral Contraceptives in Healthy Female Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2025-04-29

Brief Summary

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The purpose of this study is to evaluate the effect of SUZ on the pharmacokinetics of oral contraceptives.

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Detailed Description

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This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: SUZ with Drospirenone/Ethinyl Estradiol (DRSP/EE)

Participants will receive a single dose of DRSP/EE on Days 1 and 20. Participants will also receive SUZ every 12 hours (q12h) from Days 7 through 25.

Group Type EXPERIMENTAL

Suzetrigine

Intervention Type DRUG

Tablets for Oral Administration.

DRSP/EE

Intervention Type DRUG

Combination Tablets for Oral Administration.

Part B: SUZ with Norgestimate/Ethinyl Estradiol (NGM/EE)

Participants will receive a single dose NGM/EE on Days 1 and 22. Participants will also receive SUZ every 12 hours (q12h) from Days 9 through 29.

Group Type EXPERIMENTAL

Suzetrigine

Intervention Type DRUG

Tablets for Oral Administration.

NGM/EE

Intervention Type DRUG

Combination Tablets for Oral Administration.

Interventions

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Suzetrigine

Tablets for Oral Administration.

Intervention Type DRUG

DRSP/EE

Combination Tablets for Oral Administration.

Intervention Type DRUG

NGM/EE

Combination Tablets for Oral Administration.

Intervention Type DRUG

Other Intervention Names

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VX-548 SUZ

Eligibility Criteria

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Inclusion Criteria

* Body mass index of 18.0 to 30.0 kilogram per meter square (Kg/m\^2)
* A total body weight greater than (\>) 50 kilogram (kg)
* Nonsmoker or ex-smoker for at least 12 months before screening

Exclusion Criteria

* History of febrile or acute illness that has not fully resolved by 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion
* Relative contraindications to hormonal estrogen therapy that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. This may include, but is not limited to, intolerance to hormonal contraceptives; hypertension; history of deep vein thrombosis; coronary artery disease; cardiovascular disease; systemic lupus erythematosus; migraine; history of breast or cervical cancer; cirrhosis; and history of liver cancer.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes